FDA Releases Final Rule On Mobile Health Apps

The U.S. Food and Drug Administration has issued final guidance for mobile medical application developers, promising limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps.

The FDA will exercise “enforcement discretion,” under the Federal Food, Drug & Cosmetic Act, for the majority of mobile apps “as they pose minimal risk to consumers,” the agency said in a media release. Among those are apps helping patients self-manage their disease or conditions “without providing specific treatment or treatment suggestions,” such as for tracking exercise and diet, automating health tasks or communicating with providers via EHRs.

Instead, the FDA will focus “on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended,” such as apps designed to detect melanoma. The FDA is generally categorizing medical apps it will regulate into those intended for use as a medical device accessory (like an app that lets clinicians view medical images on a smartphone or tablet) and those using mobile platforms as a medical device (like an app that use a smartphone as an ECG to detect abnormal heart rhythms).

“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a media release. “The FDA’s tailored policy protects patients while encouraging innovation,” he said. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The FDA said it received more than 130 comments on the draft guidance, first issued in July 2011, with industry representatives, providers and other stakeholders “overwhelmingly” supporting the risk-based approach already applied to medical devices.

HHS has already approved 100 mobile medical applications over the past decade, about 40 of them in the past two years. Among the apps on the market currently are some of the more complex, potentially high-risk apps the FDA is going to regulate, like apps using smartphone technology to detect abnormal cardiac rhythms or act as an ultrasound device — tools that are going to be used by both patients and clinicians.

In related FDA action, the agency issued Sept. 20 a final rule regarding unique medical identifiers, aimed at keeping track of devices, such as pacemakers.